sterile processing

Medical Terminology Study Guide

Common Prefixes

Prefix

Meaning

hemi-

half

endo-

within

hyper-

above, excessive

hypo-

below, deficient

pre-

before

sub-

under, beneath

supra-

above

bi-

two, both sides

para-

beside, near

peri-

around, about

post-

after

Common Suffixes

Suffix

Meaning

-ectomy

surgical removal

-ac, -al, -ic, -eal, -ary, -ous

pertaining to

-cide

kill

-itis

inflammation

-cise

cut

-oscopy

visual examination of an organ or joint

-ostomy

creation of a new opening

-pexy

surgical fixation

-plasty

surgical repair/restoration

-rrhaphy

to suture

-tome

cutting instrument

Common Root Words

Root

Meaning

gastro

stomach

colo

colon

arthro

joint

cardio

heart

chole

bile

cholecyst

gallbladder

costo

rib

gyne

woman

hema

blood

hepat

liver

cranio

skull

herni

rupture

hyster

uterus

lipo

fat

litho

stone

oophor

ovary

rhino

nose

tracheo

trachea

Medical Terms & Procedures

Hemigastrectomy

  • hemi = half

  • gastro = stomach

  • ectomy = surgical removal

  • Meaning: Removal of half of the stomach

Hemicolectomy

  • hemi = half

  • colo = colon

  • ectomy = surgical removal

  • Meaning: Removal of half of the colon

Laparoscopy

  • Visual examination of organs in the abdomen

Colostomy

  • Creation of a new opening from the colon to the body surface

Orchiopexy

  • Surgical fixation of an undescended testicle into the correct position

Rhinoplasty

  • Surgical repair of the nose

Dermatome

  • Instrument used for cutting skin

Lithotripsy

  • Crushing of a stone

Tracheostomy

  • Surgical opening into the trachea


Surgical Abbreviations

ACL

Anterior Cruciate Ligament

  • Procedure: Reconstruction or repair of the anterior cruciate ligament

BSO

Bilateral Salpingo-Oophorectomy

  • Surgical removal of:

    • Both fallopian tubes

    • Both ovaries

BKA

Below Knee Amputation

CABG

Coronary Artery Bypass Graft

  • Creation of a new blood supply to an area of the heart affected by a blocked artery

CR

Closed Reduction

  • Treatment of a fractured bone without surgical incision

D & C

Dilation and Curettage

  • Dilating the cervix

  • Removing the uterine lining using a curette

ORIF

Open Reduction Internal Fixation

  • Surgical alignment and fixation of fractured bones


Important Anatomy Terms

Artery

A blood vessel carrying oxygenated blood and nutrients from the heart to the body.

Gallbladder

Stores bile produced by the liver.

Liver

Produces bile and performs many metabolic functions.

Colon

Part of the large intestine.

Trachea

Airway connecting the throat to the lungs.

Uterus

Female reproductive organ where a fetus develops.

Ovary

Female reproductive organ that produces eggs.

Rib

Bones that protect the chest organs.

Skull

Protective bony structure surrounding the brain.


Exam Memorization Tips

Remember:

  • -ectomy = remove

  • -ostomy = create an opening

  • -oscopy = look/examine

  • -plasty = repair

  • -pexy = fixation

  • -itis = inflammation

  • -rrhaphy = suture

  • -tome = cutting instrument

Examples:

  • Hemicolectomy = remove half the colon

  • Tracheostomy = create opening in trachea

  • Rhinoplasty = repair nose

  • Lithotripsy = crush stone

  • Colostomy = create opening into colon


Sterility & Sterilization

Sterility Assurance Level (SAL)

  • Probability of a viable microorganism being present on a product unit after sterilization.

Permissible Exposure Limits (PEL)

  • Developed by OSHA to indicate the maximum airborne concentration of a contaminant to which an employee may be exposed over a specified duration.

Time Weighted Average (TWA)

  • Employee’s average airborne exposure during an 8-hour work shift of a 40-hour work week.

  • Should not be exceeded.

Alkylation

  • Process by which Ethylene Oxide (EtO) destroys microorganisms, resulting in the inability of the cell to normally metabolize, reproduce, or both.

Oxidation

  • Chemical breakdown of nutrients for energy.


Ethylene Oxide (EtO)

EtO PEL 8-Hour TWA

  • 1.0 ppm

Residual (EtO)

  • Amount of EtO that remains inside materials after sterilization.

EtO Sterilizer Requirements

  • Located in a well-ventilated area.

  • Room air exchange rate of at least 10 changes per hour.

  • Ventilation systems and exhaust lines, including floor drains, should be periodically checked by qualified personnel.

Minimum Product Aeration Recommendations

  • 8 hours at 140°F

  • 12 hours at 122°F

Personnel Monitoring

  • Passive diffusion monitor attached to employee clothing.

  • Positioned in breathing zone within one foot of the nose.

Removing Loads from Non-Aeration Sterilizers

  • Door opened 6 inches for 15 minutes before removing load.

  • Carts should be pulled to minimize exposure.

  • Load placed immediately into aerator.

  • Do not add new loads once aeration has begun.

Sterilizer Performance Monitors (EtO)

  • Pressure gauges

  • Temperature controls

  • Charts

  • Graphs

  • Chemical indicators

  • Biological indicators

  • Bacillus atrophaeus

EtO Cycle Times

  • 1–4 hours exposure

  • 8–12 hours aeration

  • 8 hours aeration at 140°F

  • 12 hours aeration at 122°F

  • Kills by alkylation

Biological Indicator for EtO

  • Bacillus atrophaeus


Hydrogen Peroxide / Gas Plasma

Biological Indicator

  • Geobacillus stearothermophilus

Cycle Time

  • 28–50 minutes

  • Depends on equipment and load

  • Kills by oxidation

Packaging

  • Nonwoven polypropylene

  • Tyvek


Ozone Sterilization

Ozone PEL 8-Hour TWA

  • 0.1 ppm

Cycle Time

  • Approximately 4 hours

  • No sterilant to handle

  • No aeration required

  • Kills by oxidation

Biological Indicator

  • Geobacillus stearothermophilus


Inventory Management

Consumable Inventory Cycle

  1. Purchase

  2. Store

  3. Use

  4. Discard

Par-Level System

  • Desired inventory amount established.

  • Replenishment restores products to that level.

Automated Supply Replenishment System

  • Items automatically identified and tracked.

  • Reorder point generates pick list.

  • Items issued and transferred to user area.

Exchange Cart System

  • Desired inventory placed on assigned cart.

  • Duplicate cart maintained elsewhere.

  • Carts exchanged daily.

Requisition System

  • Items requested by user department personnel.

Perpetual Inventory System

  • Tracks all incoming and issued supplies.

Distribution

  • Movement of supplies throughout the facility.

ABC Analysis

  • Inventory management strategy.

  • Focus first on high-value items (A items).

  • Last focus on low-value items (C items).

Inventory Service Level

  • Percentage of items filled when an order is placed.

Inventory Stock-Out Rate

  • Percentage of items not filled when an order is placed.


Patient Care Equipment

Patient Care Equipment

  • Portable equipment used to assist in patient care and treatment.

Biomedical/Clinical Engineering Department

  • Performs safety inspections and function tests on medical equipment.

CPM (Continuous Passive Motion Device)

  • Treats synovial joints:

    • Hip

    • Knee

    • Ankle

    • Shoulder

    • Elbow

    • Wrist

  • Moves affected joint continuously without patient assistance.

Hypothermia Unit

  • Pumps heated or cooled water through a coiled pad.

  • Raises or lowers body temperature therapeutically.

Infusion Pump

  • Mechanically controls administration of IV therapy fluids.

PCA (Patient-Controlled Analgesia) Pump

  • Allows automatic self-administration of pain medication.

Sequential Compression Unit

  • Helps prevent:

    • Deep vein thrombosis (DVT)

    • Peripheral edema

Wound V.A.C. Therapy

  • Negative pressure wound therapy.

  • Uses controlled suction to:

    • Close large wounds

    • Promote faster healing

Patient Care Equipment Storage

  • Prepared for use.

  • Stored in ready-to-dispense condition.

Central Service Responsibilities

  • Dispense

  • Track

  • Retrieve

  • Clean/Decontaminate

  • Reassemble

  • Store

Reasons to Track Equipment, Instruments & Supplies

  • Quickly locate items

  • Determine replacement needs

  • Measure usage

  • Maintain sterilization records

  • Maintain distribution records

  • Support quality processes

  • Financial analysis


Quality Management

Internal Customer

  • Physicians, nurses, and other healthcare professionals served by Central Service.

Quality

  • Consistent delivery of products and services according to established standards.

Quality Focus

  • Quality is measured through the eyes of the customer.

  • The patient must be at the center of every quality concern.

Excellent Products & Services

  • Meet needs.

  • Perform as intended.

  • Products should be complete, properly assembled, and defect-free.

Process Improvement

  • Identifies and resolves work-related problems causing poor quality.

  • Eliminates root causes of process performance issues.

Steps of Quality Planning

  1. Identify needs

  2. Identify process

  3. Compare steps and outcomes

  4. Plan process

  5. Measure

Principles of Quality Management

  • Patient focus

  • Process management

  • Continuous quality improvement

  • Fact-based decisions

Failure Mode and Effect Analysis (FMEA)

  • Predicts adverse outcomes from human or machine failures.

  • Used to prevent future adverse events.

Root Cause Analysis (RCA)

  • Looks backward at an event.

  • Helps prevent recurrence.

Total Quality Improvement (TQI)

  • Measures current process output.

  • Modifies processes to:

    • Increase output

    • Increase efficiency

    • Increase effectiveness

Four Areas of TQI Improvement

  1. Input

  2. Throughput

  3. Output

  4. Outcome

 

Chapter 1: Introduction to Central Service

What is Central Service?

  • Centralized distribution of supplies to all customers in the hospital.

One-Way Workflow

  1. Decontamination (Soiled)

  2. Preparation, Packaging, Sterilization (Clean)

  3. Sterile Storage (Sterile)

Purpose of One-Way Workflow

  • Prevents cross-contamination.


SPD Attire Requirements

Decontamination Area

Wear:

  • Scrubs

  • Hair cover

  • Shoe covers

  • Gown

  • Eye goggles

  • Face shield

  • Gloves

  • Face mask

Assembly & Sterile Storage

Wear:

  • Scrubs

  • Hair cover

Operating Room (OR)

Wear:

  • Scrubs

  • Hair cover

  • Face mask (may be required)

Normal Traffic Areas

  • Regular street attire


Environmental Controls in SPD

Decontamination Area

  • Temperature: 60–65°F

  • Humidity: 30–60%

  • Air Exchanges: 10 per hour

Prep and Pack Area

  • Temperature: 68–73°F

  • Humidity: 30–60%

  • Air Exchanges: 10 per hour

Sterile Storage

  • Temperature: 75°F or lower

  • Humidity: Less than 75%

  • Air Exchanges: 4 per hour


Processing Cycle

  1. Use

  2. Return

  3. Identify

  4. Clean

  5. Assemble

  6. Package

  7. Sterilize

  8. Store

  9. Deliver


Cleaning and Decontamination

Cleaning

AAMI Definition:

  • Removal of contamination from an item to the extent necessary for further processing or intended use.

Decontamination

  • Physically or chemically renders instruments/equipment contaminated with harmful microorganisms safe to handle.

Three-Sink Setup

Sink 1

  • Water and detergent

Sink 2

  • Intermediate rinse

  • Plain deionized water

Sink 3

  • Final rinse

  • Deionized water


Preparation, Packaging, and Sterilization Area

Functions

  • Inspect items for cleanliness

  • Check proper function

  • Check defects

  • Assemble instrument sets

  • Package and label items for sterilization

Air Pressure

  • Positive air pressure


Infection Control

Contamination

  • State of being soiled or infected by contact with infectious organisms or other material.

Standard Precautions

  • Treat everyone and everything as infected/contaminated.

Nosocomial Infection

  • Hospital-acquired infection.


Air Flow

Negative Air Flow

  • Air flows into the room from surrounding areas.

  • Pressure is less than adjacent areas.

Positive Air Pressure

  • Air flows out of the room.

  • Helps keep dust particles and microorganisms out.


Packaging

Wrapping Techniques

  • Sequential

  • Simultaneous

Fold Techniques

  • Square Fold

  • Envelope Fold

Weight Limits

Wrapped Instrument Sets

  • Maximum 16 lbs

Containerized Instrument Sets

  • Maximum 25 lbs

Wrapped Basin Sets

  • Maximum 7 lbs


Wet Packs

Definition

  • Containers with moisture present after sterilization is complete.


Sterility

Time-Related Sterility

  • Package remains sterile until expiration date.

Event-Related Sterility

  • Package remains sterile unless package integrity is compromised.

Event-Related Sterility Depends On

  1. Quality of wrapping material

  2. Handling procedures

  3. Storage and transport conditions

  4. Number of times package is handled

Packaging Concerns

  1. Moisture contamination

  2. Dirt, dust, debris

  3. Physical damage

  4. Breakdown of packaging material due to age/wear


Sterile Storage

Environmental Requirements

  • Temperature: 72–78°F

  • Relative Humidity: 30–60%

Storage Distances

Exterior Walls

  • At least 2 inches away

Floor

  • 8–10 inches above floor


Instrument Lubrication

Purpose

  • Extends instrument life

  • Makes instruments easier for surgeons to use

Application Areas

  • Hinges

  • Moving parts

  • Sliding components


Microbiology

Common Stain Tests

Gram Stain

  • Purple = Gram Positive

  • Pink = Gram Negative

Ziehl-Neelsen Stain

  • Acid-fast stain

  • Bright red

MRSA

  • Methicillin-Resistant Staphylococcus aureus

VRE

  • Vancomycin-Resistant Enterococcus

Bacterial Reproduction

  • Binary Fission

Spore

  • Resistant form of bacteria capable of surviving adverse conditions through formation of a thick protective wall.


Chain of Infection

  1. Causative Agent

    • Microorganism causing infection

  2. Reservoir

    • Where infectious agent lives

  3. Portal of Exit

    • Where agent leaves reservoir

  4. Mode of Transmission

    • Method of transfer

  5. Portal of Entry

    • Route into susceptible host

  6. Susceptible Host

    • Person vulnerable to infection


Regulatory Agencies and Standards

FDA

Function

  • Regulates manufacturers of medical devices.

Medical Device Classifications

Class I

  • Low Risk

  • No pre-market approval

  • Example: Ultrasonic cleaners

Class II

  • Medium Risk

  • Requires 510(k)

  • Example: Sterilizers

Class III

  • High Risk

  • Requires Pre-Market Approval (PMA)

  • Example: Heart valves

510(k) Application

  • Used when changes are made to an existing product.

Pre-Market Approval (PMA)

  • Required for a new product.

Safe Medical Devices Act (1990)

  • Events must be reported within 10 working days.

FDA Recall Classes

Class I

  • High Risk

  • Serious injury or death possible

Class II

  • Medium Risk

  • Temporary health problems

Class III

  • Low Risk

  • Unlikely to cause health issues


Professional Organizations

CDC

Centers for Disease Control

  • Issues infection control guidelines.

EPA

Environmental Protection Agency

  • Enforces laws related to environmental protection, air and water pollution.

DOT

Department of Transportation

  • Regulates labeling and transportation of hazardous materials.

OSHA

Occupational Safety and Health Administration

  • Protects workers from workplace illness and injury.

AAMI

Association for the Advancement of Medical Instrumentation

  • Develops standards and recommended practices.

ANSI

American National Standards Institute

  • Approves standards such as AAMI standards.

AORN

Association of Operating Room Nurses

  • Promotes optimal care of surgical patients.

APIC

Association for Professionals in Infection Control and Epidemiology

  • Dedicated to infection prevention and control.

ISO

International Standards Organization

  • Global non-governmental standards organization.

Joint Commission

  • Establishes healthcare quality standards.

  • Conducts healthcare facility inspections.

NFPA

National Fire Protection Association

  • Develops fire safety standards.

USP-NF

United States Pharmacopeia-National Formulary

  • Sets standards for packaging, labeling, purity, pH, and mineral content.

WHO

World Health Organization

  • Promotes global health and combats infectious disease.

SGNA

Society of Gastroenterology Nurses and Associates

  • Establishes standards for flexible endoscope processing.

 

Regulations, Standards, and Laws

Regulation

  • Mandatory law or rule issued by a governing body.

Standard

  • Method of defining basic parameters for processes, products, services, and measurements.

Regulatory Standard

  • Benchmark mandated by a governing agency.

  • Failure to comply may result in legal penalties.

Voluntary Standard

  • Benchmark that is strongly recommended.

Statute

  • Written and enforceable law enacted by a governing body.


Personnel Safety & PPE

Fingernails in High-Risk Areas

  • Must be 1/4 inch or less.

  • Long nails may harbor microorganisms.

Donning PPE (Putting On)

  1. Shoe covers

  2. Gown

  3. Mask/Respirator

  4. Goggles

  5. Face Shield

  6. Gloves

Doffing PPE (Removing)

  1. Shoe covers

  2. Gloves

  3. Face Shield

  4. Goggles

  5. Gown

  6. Mask/Respirator

Emergency Eyewash/Shower Equipment

  • Must be accessible within:

    • 10 seconds

    • 100 feet of potential chemical exposure


Environmental Housekeeping

Role of Environmental Housekeeping in SPD

  • Floors should be wet mopped at least daily.

  • Counters and worktables should be cleaned daily.

  • Light fixtures/covers cleaned every 6 months.

  • Walls, cabinets, and racks cleaned on a scheduled basis.


Cleaning & Decontamination

Point-of-Use Preparation

  • Helps prolong instrument life.

  • Makes cleaning easier.

Manual Cleaning

  • Physically removes deposits.

  • Water temperature should remain below 110°F.

  • Ideal temperature: 80°F–109°F.

  • Prevents coagulation of proteins.

Wetting Agent

  • Reduces surface tension of liquids.

  • Allows liquid to spread and penetrate surfaces more easily.

Detergents

Functions:

  • Dislodge soil.

  • Remove soil.

  • Disperse soil.

  • Lower surface tension.

  • Keep soils suspended.

Cleaning Aluminum & Stainless Steel

  • Use a to-and-fro motion with the grain.

  • Avoid circular motion.

  • Prevents scratching and damage.

Mechanical Washers

  • Automated equipment used to:

    • Clean

    • Decontaminate

    • Disinfect

    • Dry medical devices


Medical Waste

Medical Waste Categories

  1. General Trash

  2. Regulated Medical Waste

  3. Hazardous Waste

  4. Low-Level Radioactive Waste

Regulated Medical Waste

Includes:

  • Sharps

  • Selected isolation biological waste

  • Pathological waste (human tissue, organs, body parts)

  • Human blood

Represents risk to:

  • Public health

  • Environment


Disinfection & Sterilization

Disinfectant

  • Chemical that kills most pathogenic organisms.

  • Does not kill spores.

  • Not a sterilant.

Antiseptics

  • Inhibit bacterial growth.

  • Usually applied topically.

  • Used only on living tissue.

Disinfection

  • Destruction of nearly all pathogenic microorganisms on an inanimate surface.

Thermal Disinfection

  • Uses heat.

  • Kills all organisms except spores.

Sterilization

  • Complete destruction of:

    • Bacteria

    • Viruses

    • Spores

    • Fungi

Bactericidal

  • Relating to destruction of bacteria.


Factors Affecting Disinfectant Effectiveness

  1. Type and amount of microorganisms

  2. Contact

  3. Time

  4. Temperature

  5. pH

  6. Water quality

  7. Device material

  8. Positioning of device


Types of Disinfectants

Quaternary Ammonium Compounds (Quats)

  • Low-level disinfectant

  • Cationic

  • Incompatible with soap

  • Denatures cell proteins

  • Disrupts cell membranes

Used for:

  • Floors

  • Walls

  • Furniture

  • Environmental sanitation

Not the disinfectant of choice in Central Service.


Phenolics

  • Intermediate to low-level disinfectant

  • Penetrates cell wall

  • Precipitates cell protein

  • Has residual activity

Used by:

  • Housekeeping services


Alcohol

70% Isopropyl Alcohol

  • Denatures proteins

  • Fast acting

  • Leaves no residue

  • Contact time: 2–10 minutes

Uses:

  • Flushing endoscopes after disinfection

  • Facilitates drying

  • Discourages microbial growth


Halogens

Chlorine

  • Intermediate-level disinfectant

  • Used for:

    • Dialysis machines

    • Hydrotherapy baths

    • Bathrooms

    • Laundry bleach

Iodine

  • Used in skin preparation

  • Corrosive to metals


Glutaraldehyde

High-Level Disinfectant

Uses:

  • Endoscopes

  • Ultrasonic probes

Characteristics:

  • Kills by alkylation of proteins

  • Clear solution

  • Turns green when activated

  • Sharp odor

Requirements:

  • 10 air exchanges/hour

Reuse:

  • 14–28 days

Testing:

  • Test strips

  • MEC = 1.5%

Exposure Times:

  • High-level disinfection = 25 minutes

  • Sterilization = 6–10 hours

Can be used:

  • Manually

  • Automated systems


OPA (Ortho-Phthalaldehyde)

High-Level Disinfectant

Characteristics:

  • No strong odor

  • Requires ventilation

  • 10 air exchanges/hour

Exposure Times:

  • 12 minutes at 68°F (manual)

  • 5 minutes at 77°F (AER)

Additional Facts:

  • Not a sterilant

  • No activation required

  • Kills by alkylation

  • Reuse life = 14 days

  • Shelf life = 2 years

  • MEC = 0.3%

  • Requires copious rinsing


Formaldehyde

High-Level

  • 8% formaldehyde + 70% alcohol

Intermediate-Level

  • 4%–8% formaldehyde + water

Mechanism:

  • Kills by alkylation


Packaging & Sterility Maintenance

Two Categories of Sterility Packaging

  1. Reusable

  2. Disposable

Objectives of Packaging

  • Allow sterilant penetration

  • Maintain sterility

  • Permit aseptic opening


Reusable Sterilization Materials

  1. Woven textiles

  2. Rigid sterilization containers


Disposable Sterilization Materials

  1. Pouches

  2. Nonwoven wraps


Packaging Materials

Muslin

  • Plain-weave cotton or cotton/polyester fabric

  • Approximately 140 threads per square inch

Kraft-Type Papers

  • Medical-grade paper packaging material

  • Used for many sterilization applications

SMS (Spunbond-Meltblown-Spunbond)

  • Nonwoven packaging material

  • Most popular flat wrap

Spunbond Polyolefin (Tyvek)

  • Used in gas plasma sterilization

  • Contains no cellulose

  • Compatible with hydrogen peroxide/gas plasma


Sterilization Packaging Requirements

Steam Sterilization Packaging

Must:

  • Withstand 250°F–275°F

  • Allow air removal

  • Allow steam penetration

  • Permit drying

EtO Packaging

Must:

  • Allow gas penetration

  • Permit removal of gas residue

  • Permit aeration

Gas Plasma Packaging

  • Uses compatible containers/materials that protect devices during storage and transport.

Cellulose-Based Papers/Pouches

Cannot be used in gas plasma sterilizers because:

  • Cellulose absorbs sterilant.

  • Reduces sterilant penetration.

Paper-Plastic Pouches & SMS Wraps

Acceptable for:

  • Steam sterilization

  • EtO sterilization


Steam Sterilization Concepts

Superheating

  • Occurs when steam temperature exceeds that of saturated steam at the same pressure.

Wicking Material

  • Approved absorbent material.

  • Allows:

    • Air removal

    • Steam penetration

    • Drying


Linen & Basin Set Limits

Linen Pack Size Limit

  • 12 × 12 × 12 inches

  • Maximum weight = 12 lbs

  • Maximum density = 7.2 lbs

Basin Set Limit

  • Maximum weight = 7 lbs


Package Labeling

Should Include:

  • Description of contents

  • Initials of assembler

  • Lot control number

  • Sterilizer ID and cycle

  • Date/Time


Storage Conditions

Packaging Materials Before Sterilization

Hold at:

  • Temperature: 64°F–72°F

  • Humidity: 35%–70%

  • Minimum of 2 hours before sterilization


Inventory Rotation

FIFO

First In, First Out


High-Yield Exam Facts to Memorize

  • Fingernails = 1/4 inch or less

  • Eyewash station = 10 seconds or 100 feet

  • Manual cleaning water = 80°F–109°F (below 110°F)

  • Glutaraldehyde MEC = 1.5%

  • OPA MEC = 0.3%

  • Basin sets = 7 lbs max

  • Linen packs = 12x12x12, 12 lbs max

  • Steam packaging must withstand 250–275°F

  • FIFO = First In, First Out

  • Cellulose products cannot be used in gas plasma sterilizers.

  • OPA is not a sterilant.

  • Thermal disinfection kills all organisms except spores.

  • Sterilization destroys all microbial life, including spores.